# K990055: B-400 Ceiling Mounted Possitioner, Model B-400

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, Inc.
- Decided: Feb 2, 1999 after 26 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880527 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915592: Pegasus Lateral Cardiac Positioner, Fischer Imaging Corp. (1992) Summary page 2.
- K880527: Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm, Fischer Imaging Corp. (1988) Summary page 2.
- K923813: Philips Integris V3000 Rotational Angio Function, Philips Medical Systems, Inc. (1992) Summary page 2.
- K970947: B-350 Ceiling Mounted C-Positioner, Omega Medical Imaging, Inc. (1997) Summary page 2.
- (no number) Fisher’s CPS Ceiling Mounted Imaging System: named in the summary without a submission number

## Indications for use
This device is intended to support the X-Ray Diagnostic Source Assembly and the Image Receptor. It is not designed nor intended to be used in any General Purpose X-Ray System.

Source page: https://510kreport.com/device/K990055
Methodology: https://510kreport.com/methodology